Drill assembly for accessing bone

ABSTRACT

A system and method for implanting and stabilizing spinal cord stimulators in an epidural space of the spinal column of a patient to prevent or limit axial movement of the stimulators once implanted in the epidural space. The system includes a drill assembly, a guide wire assembly, and a guide wire receiver. The drill assembly includes a cannula, a drill for creating access points in the patient&#39;s spinal column for implanting the stimulators, and an incremental drill adjuster for drilling into the patient&#39;s lamina a pre-set, discrete distance. The guide wire assembly includes a hollowed guide wire sleeve, a guide wire housed within the sleeve, and a magnet disposed on a proximal end of the guide wire assembly. The guide wire receiver includes a scoop for receiving and catching the magnet to assist in feeding the stimulators through the epidural space.

RELATED APPLICATION

The present application is a continuation patent application and claimspriority benefit, with regard to all common subject matter, ofearlier-filed U.S. patent application Ser. No. 14/948,603, filed Nov.23, 2015, entitled “DRILL ASSEMBLY FOR ACCESSING BONE,” and now issuedas U.S. Pat. No. 10,118,029 on Nov. 6, 2018 (“the '029 Patent”). The'029 Patent is a continuation patent application and claims prioritybenefit, with regard to all common subject matter, of earlier-filed U.S.patent application Ser. No. 14/230,534, filed Mar. 31, 2014, entitled“SYSTEM AND METHOD FOR STABILIZING IMPLANTED SPINAL CORD STIMULATORS,”and now issued as U.S. Pat. No. 9,192,759 on Nov. 24, 2015 (“the '759Patent”). The above-referenced patents are hereby incorporated byreference into the present application in their entirety.

BACKGROUND 1. Field

Embodiments of the invention provide a system and method for stabilizingimplanted spinal cord stimulators implanted in the epidural space of aspinal cord of a patient.

2. Related Art

Spinal cord stimulators (“SCSs” or “stimulators”) output electricalpulses to control chronic back pain. The stimulator generally comprisesan implantable pulse generator (IPG), a plurality of implantedstimulating electrodes, and conducting lead wires connecting theelectrodes to the generator. The electrodes are positioned on a leadthat is implanted in the epidural space of the spinal column proximatethe spinal cord, and multiple leads may be implanted. The IPG isimplanted subcutaneously proximate the lumbar region of the back andincludes a power supply and remote controls. The electrodes commonlycome in two forms—percutaneous form and paddle form. Embodiments of theinvention are primarily directed to percutaneous type electrodes. Thelead wires are coupled to the percutaneous leads having an array ofelectrodes and are fed through the spinal column and to the IPGimplanted in the lumbar region. A patient can then control an amount ofvoltage and current exerted by the electrodes to address chronic pain orother disorders.

Percutaneous electrodes comprise a very long, thing wire (also known asa “lead wire” or “lead line”) connected to the lead(s). A plurality ofleads may extend from the single wire, or multiple wires with one ormore leads may be implanted in the epidural space. Because thepercutaneous electrodes extend axially through the spinal column, theelectrodes are susceptible to axial movement within or dislodgement fromthe spinal column when the patient moves. This may be undesirable if theelectrodes move out of position relative to the location where thevoltage should be applied.

SUMMARY

Embodiments of the invention relate to spinal cord stimulators andsystems and methods for implanting the stimulators and preventing orlimiting axial movement of the stimulators once implanted in a patient'sepidural space of the spinal column. Embodiments of the invention arespecially adapted for use with percutaneous leads, although embodimentsmay be used with paddle stimulators. The stimulators generally compriseat least one lead and at least one lead wire connected to the lead. Thesystem of embodiments of the invention broadly comprises a drillassembly, a guide wire assembly, and a guide wire receiver. The drillassembly includes a cannula, a drill, and an incremental drill adjuster.The guide wire assembly includes a hollowed guide wire sleeve presentinga guide wire sleeve lumen and a guide wire housed within the sleevelumen. A magnet is disposed on a proximal end of the guide wireassembly.

The cannula has a handle and a hollowed cannula shaft coupled to andextending from the handle. The hollowed cannula shaft presents a cannulalumen. The drill has a drill handle and a hollowed drill shaftpresenting a drill lumen, wherein the drill shaft has proximal anddistal ends. A drill bit is provided on the proximal end of the shaft,and the drill shaft is configured to be inserted in the cannula lumen.The incremental drill adjuster is configured to advance the drill shaftby a pre-set distance upon rotation of the drill handle by 360 degreesor other pre-set rotation angle.

The guide wire receiver comprises a handle and an elongated shaft, andthe shaft has a handle end coupled to the handle and a receiving endopposite the handle end. The guide wire receiver shaft issemi-cylindrical along a portion of its length to present an open lumen,and at least a portion of the open lumen at the receiving end of theshaft is widened to provide a scoop for receipt of the magnet on theproximal end of the guide wire assembly.

The above components, in addition to other components not discussedabove in this brief summary, are utilized in the method of embodimentsof the invention. The method of embodiments of the invention broadlycomprises the below-discussed steps. First, a surgeon accesses thepatient's epidural space at the lumbar region of the patient to create afirst access point and accesses the user's epidural space at thethoracic region of the patient to create a second access point. Theepidural space is accessed at the thoracic region using the drillassembly. In contrast, the epidural space at the lumbar region may beaccessed using the drill assembly or, if penetrating only soft tissueand not bony lamina, a needle and stylet.

After creating the first and second access points, the surgeon theninserts the guide wire assembly through the second access point and intothe epidural space at the thoracic region of the patient. The guide wireassembly has proximal and distal ends, and the proximal end of the guidewire is an end closest to the patient when the guide wire is insertedthrough the second access point, and the distal end of the guide wire isopposite the proximal end and closest to a surgeon when the guide wireis inserted through the second access point. The surgeon then insertsthe guide wire receiver into the first access point at the lumbar regionof the patient. The surgeon captures the guide wire assembly with theguide wire receiver by positioning the proximal end of the guide wireassembly within the scoop of the guide wire receiver.

Upon capturing the guide wire assembly via the guide wire receiver, thesurgeon pulls, from the lumbar region, the guide wire assembly throughthe epidural space to expose a portion of the guide wire assemblyexternal to the first access point at the lumbar region. The surgeonthen removes the magnet from the guide wire assembly and removes theguide wire housed within the guide wire sleeve lumen. The surgeon feedsat least one monofilament through the guide wire sleeve lumen from oneof the lumbar or thoracic regions and to an other of the lumbar orthoracic regions. Once the monofilament is fed through the patient'sepidural space along the axial length of the patient's back, the surgeonremoves the guide wire sleeve from the epidural space and leaves inplace the at least one monofilament in the epidural space. A firstlength of the at least one monofilament is then exposed and external tothe first access point, and a second length of the at least onemonofilament is exposed and external to the second access point.

To insert the percutaneous leads into the epidural space, the surgeoncouples one end of the at least one monofilament to an end of apercutaneous lead of a spinal cord stimulator. The surgeon pulls thepercutaneous lead through at least a portion of the epidural space ofthe spinal cord by pulling on an other of the ends of the at least onemonofilament to which the percutaneous lead is not coupled. The surgeonthen positions the percutaneous lead at the desired position within theepidural space by pulling on said other end of the at least onemonofilament until the lead is in said desired position. Finally, thesurgeon anchors one of said first or second lengths of the at least onemonofilament exposed outside of the one of said first or second accesspoints and anchors the percutaneous lead wire exposed outside of theother of said first and second access points.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter. Other aspectsand advantages of the present invention will be apparent from thefollowing detailed description of the embodiments and the accompanyingdrawing figures.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

Embodiments of the present invention are described in detail below withreference to the attached drawing figures, wherein:

FIG. 1 is a schematic view of a patient's posterior side, including anillustration of the patient's spinal column and indicating a lumbarregion and a thoracic region on the patient;

FIG. 2 is an exploded perspective view of a cannula and a trocar ofembodiments of the invention;

FIG. 3 is an exploded perspective view of a drill assembly ofembodiments of the invention, particularly illustrating the cannula, adrill, and a drill stylet;

FIG. 4 is a fragmentary perspective view of the drill of FIG. 3 andparticularly illustrating a cutout in a drill handle;

FIG. 5 is a perspective view of the drill and drill stylet of FIG. 3 andparticularly illustrating the drill stylet seated within a notch of thedrill handle;

FIG. 6 is a perspective view of a drill shaft of the drill of FIG. 3 andillustrating various segments of the shaft;

FIG. 7 is a fragmentary front end view of a cannula handle of thecannula of FIG. 3, the drill handle, and the drill stylet;

FIG. 8 is a cross-sectional view taken through line 7-7 of FIG. 7;

FIG. 9 is an exploded perspective view of a needle and a needle styletof embodiments of the invention;

FIG. 10 is a fragmentary perspective view of a guide wire assembly ofembodiments of the invention and particularly illustrating a guide wiresleeve and a guide wire housed within the sleeve;

FIG. 11 is a fragmentary exploded perspective view of the needle andneedle stylet of FIG. 9 and the guide wire assembly of FIG. 10 housedwithin the needle stylet;

FIG. 12 is an exploded perspective view of an introducer and introducerstylet of embodiments of the invention;

FIG. 13 is a perspective view of a guide wire receiver of embodiments ofthe invention;

FIG. 14 is an exploded perspective view of a first angiocath ofembodiments of the invention being fed over the guide wire assembly ofFIG. 10;

FIG. 15 is a fragmentary perspective view of the introducer andintroducer stylet combination of FIG. 12 being fed over the guide wireassembly of FIG. 10;

FIG. 16a is a first end view of a scoop located on a proximal end of theguide wire receiver of FIG. 13;

FIG. 16b is a second end view of a scoop located on a proximal end ofthe guide wire receiver of FIG. 13;

FIG. 16c is a third end view of a scoop located on a proximal end of theguide wire receiver of FIG. 13;

FIG. 16d is a first perspective view of the scoop and particularlyillustrating the scoop in a fully-folded position;

FIG. 16e is a second perspective view of the scoop and particularlyillustrating the scoop in a fully-open position;

FIG. 17 is an exploded perspective view of the guide wire receiverhoused within the introducer, and the combined guide wire receiver andintroducer being fed into the cannula;

FIG. 18 is a fragmentary perspective view of the scoop of the guide wirereceiver catching a magnet coupled to the proximal end of the guide wireassembly;

FIG. 19 is an exploded perspective view of a second angiocath ofembodiments of the invention having a magnet coupled to its proximal endand being fed through the introducer stylet and introducer; and

FIG. 20 is a perspective view of a lead wire of a percutaneousstimulator, a connector, and the monofilament of embodiments of theinvention.

The drawing figures do not limit the invention to the specificembodiments disclosed and described herein. The drawings are notnecessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the invention.

DETAILED DESCRIPTION

The following detailed description of embodiments of the inventionreferences the accompanying drawings that illustrate specificembodiments in which the invention can be practiced. The embodiments areintended to describe aspects of the invention in sufficient detail toenable those skilled in the art to practice the invention. Otherembodiments can be utilized and changes can be made without departingfrom the scope of the present invention. The following detaileddescription is, therefore, not to be taken in a limiting sense. Thescope of the invention is defined only by the appended claims, alongwith the full scope of equivalents to which such claims are entitled.

In this description, references to “one embodiment,” “an embodiment,” or“embodiments” mean that the feature or features being referred to areincluded in at least one embodiment of the technology. Separatereferences to “one embodiment,” “an embodiment,” or “embodiments” inthis description do not necessarily refer to the same embodiment and arealso not mutually exclusive unless so stated and/or except as will bereadily apparent to those skilled in the art from the description. Forexample, a feature, structure, act, etc. described in one embodiment mayalso be included in other embodiments but is not necessarily included.Thus, the present technology can include a variety of combinationsand/or integrations of the embodiments described herein.

Turning now to the drawings, embodiments of the invention comprise asystem and a method for implanting and stabilizing or otherwise securingpercutaneous spinal cord stimulators 10. As shown in FIG. 20, thestimulators 10 generally comprise one or more leads 12, with the one ormore leads comprising at least one electrode (not shown) that emits anelectrical voltage. The leads 12 are connected to a lead wire 14, andthe lead wire is coupled with an implantable pulse generator 16 (IPG)(see, FIG. 1) that is implanted subcutaneously in a patient's back.Referring to FIG. 1, the patient's back has a lumbar region or end 18and a thoracic region or end 20 with the spinal column 22 axiallypositioned between the two regions. The IPG 16 is normally implanted atthe flank region or the lumbar region 18. A stabilizing system 24 ofembodiments of the invention secures the lead 12 within the epiduralspace of the spinal column 22. In embodiments, the system 24 broadlycomprises a plurality of various medical devices that are used toperform the method of embodiments of the invention. In particular, thestabilizing system 24 comprises a drill assembly 26, a guide wireassembly 28, and a guide wire receiver 30. Other components of thesystem will be described herein.

The following description will reference various orientations of thecomponents of the stabilizing system. Reference to a proximal end of aparticular component refers to the end closest to the patient when thecomponent is in use. In contrast, reference to a distal end refers tothe end opposite the proximal end and closest to the surgeon using thecomponent. Reference to a vertical axis of a component refers to theaxis along the component's length, and reference to a transverse axis ofa component refers to the axis along the component's width. If thereference directions of “proximal” and “distal” are not suitable for aparticular component, such as if the component is within the spinalcolumn, then reference will be made to a thoracic end and a lumbar end,with the thoracic end being the end closest to the thoracic region 20 ofthe patient (i.e., closer to the patient's neck), and the lumbar endbeing the end closest to the lumbar region 18 of the patient (i.e.,closer to the patient's buttocks). Finally, many of the components ofthe system 24 comprise medical devices that have hollowed shafts. Theterm “lumen” will be used herein to refer to the hollowed area or boreformed by the respective shaft, and each respective shaft's lumen willnot be given a separate reference numeral.

Many, if not most, of the components described herein are radio-opaqueso that they can be viewed under X-ray. Unless otherwise stated, it isto be assumed that in embodiments of the invention, a component isradio-opaque.

Turning now to FIGS. 2-8, the drill assembly 26 of embodiments comprisesa cannula 32, a drill 34, and an incremental drill adjuster 36. Thecannula 32 comprises a cannula handle 38 and a cannula shaft 40 that ishollowed to present a cannula lumen. A trocar 42 having a trocar cap 44and pointed shaft 46 is configured to fit within the cannula lumen. Aproximal end 48 of the pointed shaft 46 extends outside a proximal end50 of the cannula shaft 40 when the trocar 42 is housed within thecannula 32.

The cannula handle 38 includes grasping bars 52 and a cutout 54 formedin a top of the handle 38 for receipt and capturing of the trocar cap 44of the trocar 42 when the trocar 42 is coupled with the cannula 32. Thecutout 54 includes at least one horizontally-oriented channel 56 formedin a sidewall 58 of the cutout 54 for receipt of a tab 60 horizontallyextending from the trocar cap 44. A user (who is commonly a surgeon orinterventional pain physician) may position the trocar shaft 46 in thecannula lumen and then rotate the trocar cap 44 to guide the tab 60 intothe channel 56. The trocar 42 will then not be easily dislodged or movedwith respect to the cannula 32 until the user reverses rotation of thetrocar cap 44 to expose the tab 60 from the channel 56. In embodiments,the cutout 54 may include opposing channels formed in opposing sidewallsof the cutout to receive two tabs extending from the trocar. The cannulahandle 38 further includes a ball detent assembly that will be discussedfurther below and that is part of the incremental drill adjuster 36.

In some steps of the method of embodiments of the invention, the trocar42 will not be housed within the cannula 32, but it is still desirablethat the cannula be capped. In such instances, the cannula 32 willinclude a cannula cap 62 that is separate from the trocar cap 44attached to a distal end of the trocar 42. However, the cannula cap 62will be substantially the same as the trocar cap 44, except that thecannula cap 62 will include an axial cylindrical chamber 64 (see FIG. 8)therethrough to provide a passage for accessing the cannula lumen, asdescribed below. Additionally, the cannula cap 62 may include an axialtab (not shown) similar to the tab 60 on the trocar cap 44 to assistwith interfitting the cap 62 with the cannula handle 38 via a frictionfit.

The drill 34 of embodiments of the invention is illustrated in FIGS. 3-8and comprises a drill handle 66 and a drill shaft 68 coupled to thedrill handle 66 and extending therefrom. The drill shaft 68 is hollowedto present a drill lumen. A drill stylet 70 having a handle 72 and shaft74 extending therefrom is configured to fit within the drill lumen,i.e., the hollowed drill shaft 68. A proximal end 76 of the drill styletshaft 74 is configured to extend outside a proximal end 78 of the drillshaft 68 when the drill stylet 70 is housed within the drill 34, asdiscussed in more detail below. Similar to the cannula handle 38, thedrill handle 66 includes grasping bars 80 and a cutout 82 formed in atop of the handle for receipt and capturing of the drill stylet handle72 when the drill stylet 70 is coupled with the drill 34. However, thedrill handle cutout 82 is shaped differently than the cutout 54 on thecannula handle 38.

In particular, the drill handle cutout 82 includes a seat 84, sidewalls86 extending distally from the seat 84, and a notch 88 extendingproximally from the seat 84. The sidewalls 86 are complementally shapedto fit and receive the drill stylet handle 72. Referring to FIGS. 3 and7, the drill stylet handle 72 has a generally horizontally orientedshelf 90 and sidewalls 92 extending from the shelf 90. Two tabs 94extend horizontally from the shelf 90 on opposing front and rear sidesof the shelf 90. The sidewalls 92 are angled or otherwise shaped to bereceived within the cutout 54 formed in the drill handle 66, such thatthe sidewalls 92 of the drill stylet handle 72 closely match the angleand shape of the sidewalls 58 of the drill handle cutout 54.

To position the drill stylet 70 in the drill 34, the user rotates thedrill stylet 70, such that a width of the stylet handle 72 isnon-parallel to a width of the drill handle 66. The user then insertsthe drill stylet shaft 74 within the drill lumen. Once inserted, theuser can rotate the drill stylet handle 72 to a position where the drillstylet handle width is generally parallel to the drill handle width, asbest shown in FIG. 7. Upon rotation, the sidewalls 86 of the drillstylet handle 72 will closely match with the sidewalls 58 of the drillhandle cutout 54, as shown in FIG. 7. Moreover, the two tabs 94extending from the drill stylet shelf 90 will overlap a portion of thedrill handle 66 to prevent removal or dislodgement of the drill stylet70 from the drill 34, referred to as a locked position of the drillstylet 70. In embodiments, upon rotation of the drill stylet handle 72relative to the drill handle 66 to have the widths of the drill stylethandle and drill handle be substantially parallel, the tabs 94 mayslightly catch to provide a further frictional securement. In thisposition, the shelf 90 of the drill stylet handle 72 sits atop the seat84 of the drill handle 66, as shown in FIG. 7. To remove the drillstylet 70 from the drill 34, the user reverses rotation of the drillstylet handle 72, such that the drill stylet handle width isnon-parallel to the drill handle width. The user can then remove thedrill stylet shaft 74 from the drill lumen.

When the drill stylet handle 72 is seated within the cutout 54 of thedrill handle 66, the drill stylet handle 72 does not fill the notch 88that extends proximally from the seat 84. That is, the notch 88 stillpresents an open cavity 96, as best seen in FIG. 7. The purpose of thenotch 88 is to allow the drill stylet shaft 74 to be advanced fartherwithin the drill lumen. In particular, if the user reverses rotation ofthe drill stylet handle 72, such that the drill stylet handle isnon-parallel to the drill handle 66, and the user continues reversal ofrotation until the drill stylet handle 72 is approximately perpendicularto the drill handle 66, the user can then set a portion of the shelf 90of the drill stylet handle 72 within the notch 88, as shown in FIG. 5.This is accomplished by the front to rear depth of the drill stylethandle 72 being less than the transverse width of the notch 88. When thedrill stylet shelf 90 is fit within the notch 88, this in turn extendsthe proximal end 78 of the drill stylet shaft 74 outside of the proximalend 78 of the drill shaft 68 by an axial length of the notch 88. Inembodiments of the invention, the axial length of the notch (i.e., thelength of the notch along a vertical axis) is approximately 0.5-5 mm,approximately 1-4 mm, approximately 2-3.5 mm, or approximately 3 mm. Asdiscussed below in the method of embodiments of the invention, the usermay desire to extend the drill stylet shaft 74 outside of the proximalend 78 of the drill shaft 68 to test whether the user has accessed theepidural space.

The drill shaft 68 is best illustrated in FIG. 6 and presents theproximal end 78 and a distal end 98, a drill bit segment 100 (alsoreferred to herein as a “drill bit”) at the proximal end 78, astraight-sided segment 102, a detent segment 104, and a shank segment106 at the distal end 98. The segments 100,102,104,106 are integral toeach other, such that the drill shaft 68 is formed of a rigid,biocompatible material, such as steel, titanium, etc. The drill bitsegment 100 includes a plurality of flutes 108 that assist in drillinginto lamina of the patient's spinal column 22. Upon rotation of thedrill shaft 68, as described in more detail below, the flutes 108 serveto create an access point into the spinal column 22. The straight-sidedsegment 102 provides a length for the drill shaft 68, such that thestraight-sided segment 102 may be different lengths depending on the useof the drill 34 or preferences of a user of the drill. The detentsegment 104 is described in more detail immediately below. The shanksegment 106, or a portion of a length of the shank segment, is mountedwithin the drill handle 66.

The detent segment 104 is a component of the incremental drill adjuster36. The detent segment 104 provides a body 110 that is generallycylindrical along its length, except that a plurality of adjacentdetents 112 or grooves is formed along at least a portion of a length ofthe detent segment 104. In particular, the plurality of adjacent detents112 is formed on one side of the generally cylindrical detent segmentbody 110. The detents 112 are arranged side-by-side and are spacedapproximately 0.1-0.8 mm apart, approximately 0.2-0.5 mm apart, orapproximately 0.25 mm apart. That is, a length of a single detent 112from a proximal end of the detent to a distal end of the detent is0.1-0.8 mm, approximately 0.2-0.5 mm, or approximately 0.25 mm. Thelength of the detent segment 104 at the area comprising the detentsgenerally forms a longitudinal channel in the detent segment body 110,and the detents are formed in the longitudinal channel. The detents 112are formed from slightly projecting walls 114, as best illustrated inFIG. 6. Each pair of adjacent walls 114 extends from the detent segmentbody 110 to form a detent 112 therebetween, and each detent 112 presentsa trough for receipt of a portion of a ball of the ball detent assemblydiscussed in more detail below.

As noted above, the detents 112 are formed in the longitudinal channel.Extending outside the channel and circumscribing the detent segment body110 is a plurality of flutes 116, with each flute 116 generallycorresponding and aligning with a formed detent 112. Each flute 116presents a flute wall 118 that extends from the detent segment body 110.As discussed in more detail below, as the drill 34 is rotated duringinsertion in the lamina, the user of the drill may apply enough force todislodge the ball from a particular detent 112; in response to rotationof the drill handle 66, guide the ball along a flute 116 adjacent to thedetent 112 in which the ball was just located; and set the ball in oneof the other detents 112.

As shown in FIGS. 7 and 8, the drill shaft 68 is sized and configured tofit within the cannula cap 62, through the cannula handle 38, andthrough the cannula lumen. Thus, the drill stylet 70 is housed withinthe drill lumen, and the drill shaft 68 is housed within the cannulalumen. Each of these components collectively operates together, asdescribed in more detail below.

Returning to the cannula handle 38, the incremental drill adjuster 36will now be described. The adjuster 36 allows for adjusting the drill 34forward a set amount and in discrete movements so that the user is ableto control proximal movement of the drill 34 and by the set amount. Theincremental drill adjuster 36 comprises a ball detent assembly 120 andthe detent segment 104. The ball detent assembly 120 includes a ball 122and a spring 124 that loads the ball 122 in each detent 112. The detentsegment 104, which was described above, includes the plurality ofadjacent detents 112 formed in the detent segment of the drill shaft andthe corresponding flutes 116. The ball detent assembly 120 is positionedin the cannula handle 38, as best shown in FIG. 8. A side of the cannulahandle 38 is hollowed to provide a chamber 126 to receive the ball 122and spring 124. A cap 128 is fitted onto the cannula handle 38 to closeoff the chamber 126 once the ball 122 and spring 124 are position in thechamber 126. In embodiments, an end of the spring 124 may be secured toan inside of the cap, as shown in FIG. 8. In alternative embodiments,the ball 122 and spring 124 may be formed in the cannula cap 62 or oneof the ball and spring may be formed in the cannula cap 62. Therefore,it is not intended as limiting that a portion of the detent assembly 120is described above as formed in the cannula handle 38.

The ball 122 is spring-loaded, in that application of a force orpressure against the ball will compress or retract the spring 124 withinthe chamber 126. Upon the spring 124 returning to its fully extendedposition within the chamber 128, as shown in FIG. 8, the spring 124seats a portion of the ball 122 in one of the detents 112 describedabove. To actuate the drill 34 forward, the user will apply sufficientforce or pressure against the drill handle 66 to overcome the force ofthe spring 124 and push the ball 122 into the chamber 126. Due to theball 122 being spring-loaded, the user will be able to intuitively feelthe force of the spring 124 pushing the ball forward into the adjacentdetent.

To actuate proximal movement of the drill 34 (i.e., advance the drillinto the lamina or other bone), the user first locates the drill stylet70 within the drill handle 66 and in the locked position noted above.The locked position is shown in FIG. 7 and occurs when the shelf 90 ofthe drill stylet handle 72 sits atop the seat 84 of the drill handle 66.The drill shaft 68 is then positioned through the cannula cap 62 andinto the cannula lumen, as shown in FIGS. 7 and 8. The user then insertsthe drill shaft 68 through the cannula lumen and to the desired locationand then releases any rotational force applied to the drill handle 66.The release of the rotational force will seat the ball 122 into one ofthe detents 112, as shown in FIG. 8. The user can then place theproximal end 78 of the drill shaft 68 proximate the desired location onthe patient, e.g., proximate the lamina. The user will then rotate thedrill handle 66 to begin drilling into the lamina. In embodiments of theinvention, every 360 degree rotation of the drill handle 66 will advancethe drill bit approximately 1 mm, although the drill assembly 26 can besized to advance the drill shaft 68 less or more upon a single 360degree rotation. At the initial stage of drilling, the user will likelybe applying significant rotational force to advance the drill shaft 68through the lamina. However, upon drilling through the lamina, not asmuch force is required to advance the drill shaft. At this stage, theuser will take advantage of the incremental drill adjuster 36 to advancethe drill shaft 68 in set amounts. In particular, the user may choose toadvance the drill shaft 68 by only one detent length, such that thedrill shaft 68 is advancing in relatively small but discrete amounts.This is desirable if the user is attempting to access the epidural spacebut without impacting the spinal cord, which is dangerous and painfulfor the patient. If in embodiments the drill shaft 68 advancesapproximately 1 mm for every 360 degree rotation, then approximatelyevery quarter-turn or every approximately 90 degrees will seat the ball122 in the next adjacent detent 112 and advance the drill shaft 68 byapproximately 0.25 mm. The user can then incrementally adjust the drill34 to obtain a precise drilling advancement into the access point.

The drill 34 described herein is for use in inserting the stimulators10. However, it should be appreciated that the drill 34 of embodimentsof the invention could be used for other medical procedures and fordrilling through bone on other areas of a patient (both human andanimal).

In some instances the spinal column 22 can be accessed without needingto drill through the lamina. For example, in the lumbar region 18 of thepatient, there is more room between adjacent lamina, which allows moreroom for the user to maneuver between the lamina to establish an accesspoint within the spinal column. In this instance, the user need onlypenetrate soft tissue in the back to create the access point. However,in some instances in the lumbar region 18, the patient may havearthritis or other issues that require drilling through the lamina.

In the instances where only soft tissue need be penetrated and the drill34 is not required, embodiments of the invention use a needle 130 andneedle stylet 132, as illustrated in FIG. 9. The needle 130 presents asmall handle 134 and a hollowed needle shaft 136 extending therefrom andpresenting a needle lumen. The needle handle 134 has a generallycylindrical, axial opening (not shown) therethrough for the needlestylet 132. The needle stylet 132 also includes a handle 138 and aneedle stylet shaft 140, although the needle stylet shaft 140 is nothollowed to present a lumen. A proximal end 142 of the needle styletshaft 140 is pointed to assist in penetrating soft tissue. In operation,the needle stylet shaft 140 is fed through the opening in the needlehandle 134 and through the needle lumen, and in embodiments, the pointedproximal end 142 of the needle stylet shaft 136 extends outside aproximal end 144 of the needle shaft 136.

Turning now to FIG. 10, the guide wire assembly 28 of embodiments of theinvention comprises an elongated guide wire 146, a wound-wire sleeve 148surrounding the guide wire 146, and a magnet 150 coupled to a proximalend 152 of the guide wire assembly 28. The elongated guide wire 146 is along, thin section of wire that in embodiments is approximately 0.1-1.0mm in diameter, approximately 0.2-0.8 mm in diameter, or approximately0.3 mm in diameter. The wire 146 is flexible, such that it can be bentapproximately 180 degrees in any direction. A length of the wire 146 isdependent on an axial length of the patient's spinal column 22, suchthat the length of the wire should be long enough to extend axiallythrough the patient's spinal column 22 from the lumbar region 18 and tothe thoracic region 20 (or vice-versa) and with a working section(discussed below) extending from each region. Given the length of theguide wire 146, the drawings illustrate the guide wire length infragment, such as shown in FIG. 10.

The wound-wire guide wire sleeve 148, as shown in FIG. 10, substantiallycovers the guide wire 146. The sleeve 148 is formed of wire that istightly wound to present a lumen in which the guide wire 146 isinserted. The sleeve 148 provides rigidity to the guide wire assembly 28that is helpful during insertion of the guide wire assembly 28 into thespinal column 22. However, the combined guide wire 146 and sleeve 148are still flexible enough to be bent up to 180 degrees. The sleeve 148is sized and configured to be easily slidable along the length of theguide wire 146, so that the user can easily insert and remove the guidewire 146 into the sleeve lumen. The combined guide wire 146 and sleeve148 are also sized and configured to easily slide within the needlelumen, as shown in FIG. 11, the guide wire receiver, as shown in FIG.17, or an angiocath, as shown in FIG. 13 and discussed in more detailbelow.

The guide wire assembly 28 further includes the magnet 150 coupled tothe proximal end 152 of the guide wire assembly 28 and, in particular,the guide wire sleeve 148 (as opposed to the guide wire 146), as bestillustrated in FIG. 10. The magnet 150 may be coupled to the end of thesleeve 148 via any method that secures the magnet 150 and prevents itfrom becoming dislodged from the end of the sleeve 148. An exemplarysecurement method is an adhesive applied to the sleeve 148 and/or themagnet 150. In embodiments, the magnet 150 may present a hollowedchamber (not shown) at one end so that the end of the sleeve 148 may befitted within the hollowed chamber of the magnet. In embodiments, themagnet is approximately 1-3 mm in length or approximately 2 mm inlength. The magnet 150 provides sufficient magnetic attraction to amagnet on an end of an angiocath (discussed below) to draw the twomagnets together when the guide wire assembly 28 and angiocath areinserted into the epidural space.

Some steps of the method of embodiments of the invention may use acombined guide wire 146 and wound-wire sleeve 148 surrounding the guidewire 146, but in such steps, the combination guide wire 146 and sleeve148 does not include a magnet 150, or, at the least, a magnet isrequired. That is, in some steps, a combination guide wire 146 andsleeve 148 can be used that does not include a magnet. In someembodiments of the invention, a kit that is provided with the componentsof the invention includes a combination guide wire 146 and sleeve 148that does not include a magnet and a combination guide wire 146 andsleeve 148 that does include a magnet 150. But, in other embodiments ofthe invention, the provided kit includes two combination guide wires 146and sleeves 148, each with a magnet. Even though the magnet is notrequired for one of the steps, as described below, two combination guidewires and sleeves with a magnet may still be provided for ease ofmanufacturing and not having to source two different components. In yetfurther embodiments, two combination guide wires and sleeves with nomagnets are provided as a component of the kit.

Turning now to FIGS. 13, 16 a-e, 17, and 18, the guide wire receiver 30will be described. The guide wire receiver 30 is inserted into theepidural space at the lumbar region 18. The guide wire assembly 28 isinserted into the epidural space at the thoracic region 20. In generalbut discussed in more detail below, the user feeds the guide wireassembly 28 through the spinal column 22 and to the guide wire receiver30. The receiver 30 is then sized and configured to easily catch orreceive the guide wire assembly 28 so that the guide wire assembly 28can be pulled through the access point at the lumbar region 18 of thepatient's spine.

Referring to FIG. 13, the guide wire receiver 30 broadly comprises ahandle 154, a semi-cylindrical body 156 extending from the handle 154,and a receiving section 158. The handle 154 is hollowed to present ahandle lumen that connects with a guide wire receiver lumen through thebody 156. A distal end 160 of the body 156 is completely closed aboutthe cylindrical body; however, a majority of a length of the body 156 isopen to present a semi-cylindrical body section 162. As such, the guidewire receiver lumen at the semi-cylindrical body section 162 presents anopen lumen. The receiving section 158 is integrally formed with andextends from the semi-cylindrical body section 162. The receivingsection 158 is at a proximal end 164 of the guide wire receiver 30. Thesemi-cylindrical body section 162 widens at the receiving section 158 topresent a scoop 166 comprising the receiving section and for receipt ofthe magnet 150 on the end of the guide wire assembly 28, as shown inFIG. 18.

In more detail, the receiving section 158 of the guide wire receiver 30,and namely, the scoop 166, is flexible and configured to be rolled froman unfolded condition to a folded condition, as illustrated in FIGS.16a-16e . The scoop 166 extends from the distal end 160 of thesemi-cylindrical body section 162 to present sidewalls 168 and aproximal-most end 170. The sidewalls 168 of the scoop 166 are angledoutwards as the proximal-most end 170 of the scoop 166 is approached,such that the proximal-most end 170 of the scoop 166 is wider than thesemi-cylindrical body section 162 of the guide wire receiver 30. In thescoop's fully unfolded condition, illustrated in FIG. 16a , the scoop'ssidewalls 168 are generally raised as the sidewalls 168 extend from thesemi-cylindrical body section 162 of the guide wire receiver 30.However, as the sidewalls 168 widen as the proximal-most end 170 of thescoop 166 is approached, the sidewalls begin to flatten out, asillustrated in FIG. 16e . As can be seen in FIG. 16a , the sidewalls 168of the scoop 166 are not completely flat, however, even in the fullyunfolded condition, so as to present a flared proximal end.

The scoop 166 is flexible and especially designed to be “rolled up.”That is, the sidewalls 168 of the scoop 166 may be curved upwards fromthe fully unfolded position, as shown in FIGS. 16a and 16e , to afully-folded condition, as shown in FIG. 16d . In the fully-foldedcondition, proximal ends of the sidewalls 168 of the scoop 166 arealmost touching (see FIG. 16d ), are touching (not shown), or areoverlapping (not shown). The scoop 166 is thus foldable, and thisfoldable feature serves to capture the magnet 150 of the guide wireassembly 28 upon the magnet 150 being received in the unfolded scoop166. In other instances, the scoop 166 may not need to be either fullyfolded or full unfolded, and in such instances, the scoop may be foldedto intermediate positions, as shown in FIGS. 16b and 16c . The scoop 166thus provides sufficient flexibility to be rolled from the unfolded tothe fully-folded condition but also enough rigidity to hold a particularfolded incremental position during use. Use of the guide wire receiver30 will be described in more detail below.

As described below and as shown in FIG. 17, the guide wire receiver 30is fed through a lumen of an introducer 172 or epiducer. Duringinsertion, the scoop 166 is operable to roll to the fully-foldedcondition so that it can be inserted into the introducer lumen. Toinsert the guide wire receiver 30 into the introducer lumen, the usersimply places the scoop 166 (which is presently in its fully-unfoldedcondition) against a distal end 174 of the introducer 172 and beginspushing the guide wire receiver 30 through the introducer lumen. Whenthe scoop 166 is not inserted in a lumen, it is in a rest or naturalstate of the fully unfolded position of FIG. 16a . However, upon theuser beginning to insert the scoop 166 into the lumen, the scoop willbegin to fold to the fully-folded position of FIG. 16d for placementwithin the lumen. A length of the guide wire receiver 30 is longer thana length of the introducer 172, such that the scoop 166 extends beyond aproximal end 176 of the introducer, as shown in FIG. 17.

The system 24 for securing spinal cord stimulators 10 also includesvarious other components. In particular and referring to FIGS. 12, 14,15, and 19-21, the system 24 further comprises the introducer 172 (orepiducer), an introducer stylet 178, a first angiocath 180, a secondangiocath 182 having a magnet 184 at one end, at least one monofilament186, and a connector 188 for connecting the monofilament 186 to the lead12 of the percutaneous stimulators 10.

The introducer 172 of embodiments of the invention may also be what isknown in the art as an epiducer. Both the introducer 172 and epiducerinclude a handle 190 and a hollowed shaft 192 extending from the handle190 and presenting a lumen. As is known in the art, an introducertypically has a cylindrical shaped shaft, whereas an epiducer has anoval or oblong shaped shaft when viewed in horizontal cross section. Asdiscussed herein, the term “introducer” is defined to include bothcylindrically shaped and oval or oblong shaped shafts, and as such, theterm “introducer” is intended to encompass both the typical introducerand epiducer known in the art. Although not shown in the drawings, theintroducer handle 190 is hollowed so that the introducer lumen andhollowed introducer handle can receive another component therethrough,as shown in FIG. 17.

As illustrated in FIG. 12, the introducer stylet 178 is configured to beinserted into the introducer lumen. The introducer stylet 178 comprisesa handle 194, a luer 196 for removably coupling the introducer stylet178 with the introducer 172, and a hollowed introducer stylet shaft 198that includes a taper 200 at a proximal end. The introducer stylet shaft198 extends from the handle 194 and through the luer 196, and becausethe shaft is hollowed, the introducer stylet has a lumen. The shaft 198,and specifically the taper 200, is slightly flexible to provide someflexing upon application of pressure. A length of the introducer styletshaft 198 is longer than a length of the introducer shaft 192, such thatwhen the introducer stylet 178 is housed within the introducer lumen,the taper 200 extends out from the proximal end of the introducer 172.The luer 196 serves to couple the introducer stylet 178 with theintroducer 172 by fitting the luer 196 over a portion of a distal end ofthe introducer 172 and rotating the luer 196 to obtain a friction fit.

The system 24 of embodiments employs at least two and potentiallyadditional angiocaths. In embodiments, the first angiocath 180,illustrated in FIG. 14, is a conventional angiocath having a handle 202and a shaft 204 extending therefrom. The shaft 204 is generally flexibleto allow an approximately 5-45 degree radius of movement about an axiallength of the shaft. In the first angiocath 180 shown in FIG. 14, aproximal end 206 of the angiocath is substantially straight. However,the system 24 of embodiments of the invention contemplates including aplurality of angiocaths having proximal ends with various curvatures,such that the proximal end 206 is angled at a particular degree.Exemplary first angiocaths 180 include proximal ends 206 angled at 0degrees (i.e., a straight proximal end), 5 degrees, 10 degrees, 15degrees, 20 degrees, 25 degrees, and 30 degrees. The system may comprisea kit that includes some or all of the plurality of first angiocaths.

The second angiocath 182, which is illustrated in FIG. 19, issubstantially the same as the first angiocath (like reference numeralsare used to indicate like structure), except that the second angiocath182 includes the magnet 184 coupled to the proximal end 206 of theangiocath shaft 204. The magnet 184 may be secured to the proximal end206 via adhesive or other suitable securement method. The magnet 184 onthe second angiocath 182 is configured to be attracted to the magnet 150on the guide wire assembly 28, as discussed above. As discussed in moredetail below, during the method of stabilizing the spinal cordstimulators 10 in the patient, the magnet 184 on the second angiocath182 is positioned proximate the magnet 150 on the guide wire assembly 28so that the magnets are magnetically attracted to each other toremovably couple the guide wire assembly to the second angiocath toallow for pulling of the guide wire assembly through the epidural space.

Similar to the first angiocath 180, the system 24 may also include aplurality of second angiocaths 182, with each second angiocath having aproximal end with a different radius of curvature. In particular, theproximal ends of each of the second angiocaths may be angled at 0degrees (i.e., a straight proximal end), 5 degrees, 10 degrees, 15degrees, 20 degrees, 25 degrees, and 30 degrees. The system 24 maycomprise a kit that includes some or all of the plurality of secondangiocaths. The purpose of the angled proximal ends will be discussed inmore detail below.

Referring now to FIG. 20, the monofilament 186 is shown coupled to thelead 12 of the spinal cord stimulators 10. The monofilament 186 is asingle or multiple line of thin wire that is flexible and can be rolledor coiled upon itself, as shown in FIG. 20. However, the monofilament186 also has enough rigidity to be guided into location and manipulatedwithin the epidural space. In embodiments, the monofilament 186 isthinner in diameter than a diameter of the guide wire 146. Themonofilament 186 is biocompatible, and in embodiments, the monofilament186 is formed of carbothane. The monofilament 186 is of a length thatcan extend the length of the patient's back and provide additionalextraneous length at both the lumbar and thoracic regions 18,20. Inembodiments, a plurality of monofilaments 186 may be provided with thesystem 24 if multiple leads 12 are also used.

The connector 188 is also shown in FIG. 20 and is, in embodiments, arelatively small piece of carbothane tubing that is configured to couplethe monofilament 186 to the percutaneous lead 12. In embodiments, theconnector 188 is a cylindrical section of tubing that can receive an endof the monofilament 186 in one end of the connector 188, and an end ofthe lead 12 in the other end of the connector 188. The respective endsof the monofilament and lead are operable to be friction fit within theconnector. The user can apply adhesive or another permanent couplingsolution to securely couple the monofilament with the connector and thelead with the connector. In embodiments, the connector 188 isbiocompatible, as it will be permanently implanted in the patient'sepidural space, as discussed in more detail below.

The method of embodiments of the invention will now be described. Themethod comprises steps for using the system 24 of embodiments to secureand stabilize the percutaneous spinal cord stimulators 10 in thepatient's spinal column 22. The steps of the method need not beperformed in the order presented below, unless expressly statedotherwise. Additionally, it should be appreciated that some steps may becombined into a single step, and some steps may be skipped altogether.Due to the nature of performing an invasive surgery on a patient, theuser of the system may decide during the surgery to alter the performedsteps described below.

To begin, the user (who is commonly a surgeon or other physician trainedin spinal surgery and who will be referred to below as a surgeon)prepares the lumbar region 18 of the patient and creates a first accesspoint. As noted above, the lumbar region 18 is at the tail of thepatient's spine near the patient's buttocks. The surgeon will evaluatewhether the drill assembly 26 is needed to access the epidural spacethrough the patient's lamina. As noted above, in some patients the spacebetween vertebrae is small, such as may be due to arthritis, whichrequires the surgeon to access the epidural space via the lamina.Because the lamina is bone, the drill assembly 26 of embodiments of theinvention is required. However, for other patients, the surgeon may beable to access the epidural space through the soft tissue betweenadjacent lamina. In this instance, only the needle 130 and needle stylet132 combination of embodiments of the invention is needed.

If the drill assembly 26 is needed to access the epidural space, thesurgeon will locate the cannula 32 and trocar 42 combination on thelamina. The trocar 42 is then removed from the cannula 32, leaving onlythe cannula 32. The drill 34 and drill stylet 70 combination is theninserted into the cannula 32. To initiate drilling through the lamina,the surgeon will apply an appropriate rotational force to the drillhandle 66 to rotate the drill handle. As discussed above, an approximate360 degree rotation of the drill handle 66 will effect an approximate 1mm advanced of the drill shaft 68 through the lamina. As can beappreciated, drilling through the bony lamina will require anappropriate force applied to the drill handle 66 from the surgeon ascompared to advancing the drill shaft 68 through soft tissue, forexample, or incrementally advancing the drill shaft once the epiduralspace is reached. Once the surgeon successfully drills through thelamina, the surgeon will then take advantage of the incremental drilladjuster 36 to advance the drill shaft 68 in set amounts, as discussedabove. Once the lamina, or most of the lamina, is penetrated, theepidural space is reached to create a first access point. The surgeonmust be careful to fully access the epidural space and provide a cleanand open access point but also not advance the drill shaft 68 so farinto the epidural space as to touch the spinal cord. The incrementaldrill adjuster 36 allows for this fine precision once the majority ofthe lamina is drilled through. The surgeon will rotate the drill handle66 to advance the ball 122 to the next adjacent detent 112, as discussedabove. Advancement by one detent length corresponds to approximately aone-quarter turn of the handle and 0.25 mm drill shaft advancement. Thesurgeon is normally performing the operation under X-ray so that thesurgeon can see where the drill bit segment 100 is in relation to thelamina and when the drill bit segment 100 penetrates the lamina andenters the epidural space. Once the lamina is fully penetrated, thesurgeon uses a blunt probe (not shown) to insure a clean and fully-openaccess point to the epidural space.

In embodiments of the invention, the surgeon may alternatively use thedrill stylet 70 to insure that the epidural space is reached. Asdiscussed above, the drill stylet 70 is inserted into the drill lumen.The drill stylet 70 and drill handle 66 are configured to allow thedrill stylet 70 to be housed within the drill lumen in two positions. Afirst position, shown in FIG. 7, is where the drill stylet shelf 90 isseated on the drill handle seat 84, such that the open cavity 96 of thenotch 88 notch is exposed. A second position is shown in FIG. 5 and iswhere the drill stylet 70 is rotated 90 degrees (from the position shownin FIG. 7), such that a portion of the drill stylet handle 72 is seatedwithin the notch 88. In this position, the proximal end of the stylet 76extends outside of the proximal end of the drill shaft 78 (i.e., outsidea proximal end of the drill bit segment 100), as also shown in FIG. 5.Moving the drill stylet 70 to the second position with respect to thedrill 34 allows the surgeon to insure that the epidural space isidentified and accessed without touching the spinal cord, which as notedabove, is dangerous and painful for the patient. Due to a length of thenotch 88 in the drill handle 66, the proximal end 76 of the drill stylet70 is allowed to advance outside the proximal end 78 of the drill shaft68 by approximately the length of the notch 88. This length is enoughfor the surgeon to identify under X-ray that the epidural space isaccessed, but not enough length to touch the spinal cord.

Once the surgeon identifies the epidural space, the surgeon then removesthe drill 34 from the cannula 32, leaving only the cannula 32. Thesurgeon will then feed the guide wire assembly 28 through the cannula 32and through first access point. The surgeon removes the cannula 32distally, leaving only the guide wire assembly 28 penetrating the firstaccess point. The surgeon then insures that the introducer stylet 178 ishoused within the introducer lumen. As shown in FIG. 15, the combinationintroducer 172 and introducer stylet 178 are then fed over the guidewire assembly 28 penetrating the first access point so that theintroducer and introducer stylet penetrate through the first accesspoint. The surgeon then removes the guide wire assembly 28 from theintroducer 172 and introducer stylet 178 combination by pulling theguide wire assembly 28 distally through the introducer stylet lumen. Thepurpose of first placing the guide wire assembly 28 through the firstaccess point prior to placement of the introducer 172 and introducerstylet 178 combination is to provide rigidity to the introducer 172 andintroducer stylet 178 combination to prevent the introducer stylettapered end 200 from touching or penetrating the spinal cord and tofurther provide a guide for insertion of the introducer and introducerstylet combination.

If the drill 34 is not needed to access the epidural space at the lumbarregion 18, such as may be the case if the surgeon can access theepidural space through soft tissue, then the surgeon may optionally onlyuse the needle 130 and needle stylet 132 illustrated in FIG. 9. Thesurgeon inserts the stylet 132 through the needle lumen and then usesthe needle 130 and stylet 132 combination to penetrate the soft tissueto create the first access point. The surgeon then removes the stylet132 and inserts the guide wire assembly 28 through the needle lumen, asshown in FIG. 11. Once the guide wire assembly 28 is inserted throughthe first access point, the surgeon removes the needle 130, leaving onlythe guide wire assembly 28. The surgeon then performs the followingsteps, similar to if the drill 34 was used to create the first accesspoint, as described above. In particular, the surgeon then insures thatthe introducer stylet 178 is housed within the introducer lumen. Thecombination introducer 172 and introducer stylet 178 are then fed overthe guide wire assembly 28 penetrating the first access point so thatthe introducer and introducer stylet penetrate through the first accesspoint, as shown in FIG. 15. The surgeon then removes the guide wireassembly 28 from the introducer 172 and introducer stylet 178combination by pulling the guide wire assembly 28 distally through theintroducer stylet lumen. The surgeon removes the introducer stylet 178,leaving only the introducer 172 at the first access point.

The surgeon next creates a second access point at the patient's thoracicregion 20. As should be appreciated, the surgeon may first create anaccess point at the thoracic region and then create an access point atthe lumbar region, or vice-versa. Reference to first and second accesspoints is not intended to imply that one access point must be surgicallybe performed before another access point.

The surgeon will prepare the surgical area on the patient atapproximately T4 or T5 in the thoracic region 20. Once the surgeonidentifies a preferred second access point, the surgeon inserts thecombined cannula 32 and trocar 42 onto the lamina. Similar to the lumbarregion 18 and creation of the first access point with the drill 34, thesurgeon removes the trocar 42 from the cannula 32 and inserts the drill34 and the drill stylet 70 into the cannula lumen. The surgeon thenadvances the drill 34 through the lamina to create the second accesspoint. In embodiments that set the drill at advancement of 1 mm based ona single 360 degree rotation of the drill handle 66, the surgeon willnormally advance the drill in 1 mm increments. Advancement of the drillis substantially similar to the steps described above for the lumbarregion. Upon drilling through, or almost through, the lamina, thesurgeon may choose to advance the drill in 0.25 mm increments using theincremental drill adjuster 36, as described above. Once the epiduralspace is identified, the surgeon will then use a blunt probe (not shown)to test for the epidural space or use the drill stylet 70, as describedabove for the lumbar region 18.

After the surgeon creates the second access point at the thoracic region20, the surgeon removes the drill 34 and drill stylet 70 from thecannula lumen, leaving the cannula 32 on the lamina. At this next step,the surgeon inserts the guide wire assembly 28 through the cannula 32,into the second access point, and into the epidural space at thethoracic region 20. In some circumstances, the surgeon may havedifficulty in inserting the guide wire assembly 28 through the cannula32 and into the epidural space. In particular, the angle of insertionthrough the second access point and into the epidural space may notallow for easy insertion. In such circumstances, the surgeon may insertone of the plurality of first angiocaths 180 through the cannula lumen.As noted above, the system 24 of embodiments of the invention includesthe plurality of first angiocaths 180, with each angiocath having aproximal end with a different angle of curvature. Under X-ray, thesurgeon will be able to view the required angle of curvature. Uponinserting the first angiocath 180 into the epidural space, the surgeoninserts the guide wire assembly 28 through the angiocath lumen, as shownin FIG. 14 (note that for ease of illustration, FIG. 14 does notillustrate the first angiocath 180 into the cannula lumen, as describedabove). The guide wire assembly 28 is inserted with the magnet 150 atthe proximal end, so that the magnet 150 is inserted first through thefirst angiocath 180. The first angiocath's proximal end then assists inpositioning the guide wire assembly 28 into the epidural space andaxially through the spinal column. The surgeon then uses the firstangiocath 180 to direct the guide wire assembly 28 into the midline ofthe thoracic epidural space. Once the guide wire assembly 28 is inplace, the surgeon removes the first angiocath 180.

Returning to the lumbar region 18, recall that the introducer 172 aloneis positioned at the first access point. The guide wire assembly 28 hasbeen removed from the introducer 172. At this point, the surgeon insertsthe guide wire receiver 30 through the introducer lumen and into thefirst access point. Operating under X-ray, the surgeon advances theguide wire assembly 28, which is inserted through the second accesspoint at the thoracic region 20, towards the guide wire receiver 30inserted through the first access point at the lumbar region 18. Thesurgeon uses the guide wire receiver 30 to catch the guide wire assembly28 being pushed from the thoracic end 20 and towards the lumbar end 18,as shown in FIG. 18. The sidewalls 168 of the scoop 166 of the guidewire receiver 30 surround and hold the magnet 150 of the guide wireassembly 28 within the scoop 166 as the surgeon advances the guide wireassembly 28 into the semi-cylindrical body section 162 of the guide wirereceiver 30.

In some instances, the surgeon may have difficulty catching the guidewire assembly 28 with the scoop 166 alone. In such circumstances, thesurgeon inserts one of the plurality of second angiocaths 182 throughthe guide wire receiver lumen, as shown in FIG. 19. Recall that thesecond angiocath 182 has the proximal end provided with the magnet 184.When the proximal end of the second angiocath 182 extends outside theguide wire receiver lumen (e.g., when the magnet 184 is proximate thescoop 166), the magnet 184 on the second angiocath 182 is magneticallyattracted to the magnet 150 on the guide wire assembly 28. Upon the twomagnets 150,184 magnetically coupling, the surgeon can pull the secondangiocath 182 distally from the guide wire receiver 30 to position theproximal end of the guide wire assembly 28 within the scoop 166 and intothe guide wire receiver lumen. Once the guide wire assembly 28 iscaptured within the guide wire receiver 30, the surgeon pulls the guidewire receiver 30 distally from the introducer lumen to pull the guidewire assembly 28 distally through the first access point. The surgeonthus removes the guide wire receiver 30 from the introducer lumen,leaving only the introducer 172 fed over the guide wire assembly 28. Atthis time, the guide wire assembly 28 extends through the patient'sspinal column and both of the first and second access points.

Working at the lumbar region 18, the surgeon next cuts the proximal end152 of the guide wire assembly 28 external to the first access pointproximal the magnet 150. In essence, the surgeon cuts the magnet 150 offof the guide wire assembly's proximal end 152. Due to the relativelysmall diameter of the guide wire assembly 28, the surgeon can easily cutthrough the guide wire sleeve 148 and guide wire 146 with surgicalscissors or wire cutters. Once the magnet 150 is cut off the guide wireassembly 28, the guide wire 146 internal to the guide wire sleeve 148 isexposed. The surgeon removes the guide wire 146 from the sleeve 148 toleave only the guide wire sleeve 148 extending through the patient'sspinal column. Note that in embodiments of the invention, a distal endof the guide wire assembly 28 is not closed, such that the guide wire146 within the guide wire sleeve 148 is exposed. Therefore, the surgeonmay remove the guide wire 146 from either the lumbar 18 or thoracic ends20 of the patient's back. In alternative embodiments where the guidewire assembly 28 is closed at the distal end, the surgeon cuts the guidewire assembly proximate the distal end to expose the guide wire 146within the sleeve 148, as is done for the proximal end 152, in the eventthe surgeon desires to remove the guide wire 146 from the sleeve 148 viathe thoracic end 20.

The surgeon then feeds the monofilament 186 through the guide wiresleeve 148 from the lumbar end 18 and to the thoracic end 20. Once themonofilament 186 is fed through the guide wire sleeve 148, themonofilament 186 extends through the patient's spinal column 22 andexternal both the first and second access points. The surgeon thenremoves the guide wire sleeve 148 from the patient's spinal columnthrough either the first or second access point. The guide wire sleeve148 provides a sufficient stiffness through the epidural space to allowthe monofilament 186 to be positioned in the epidural space. At thistime, the monofilament 186 is positioned through the first access point,through the epidural space of the patient's spinal column, and throughthe second access point at the thoracic region 20.

The surgeon is now ready to insert the spinal cord stimulator 10 intothe patient's epidural space. As discussed above, the stimulator 10 mayhave a plurality of leads 12 (otherwise known as an array of leads) thatis one or more electrodes. Each lead 12 is attached to a lead wire 14that is eventually coupled with the IPG 16. To feed each lead 12 throughthe epidural space of the patient's spinal column 22, the surgeon usesthe connector 188 to connect the lead 12 with the monofilament 186. Ininstances where more than one lead 12 is used, the surgeon may insertmultiple monofilaments 186 through the epidural space, so that each lead12 is individually coupled with a monofilament 186. It should beappreciated that in embodiments of the invention, there is a one-to-oneratio of leads to monofilaments. It is common for the surgeon to place aplurality of leads through the epidural space, and therefore,embodiments of the invention contemplate positioning a plurality ofmonofilaments through the epidural space. Note that in alternativeembodiments, one lead wire 14 may be connected to a plurality of leads12.

Working at the lumbar region 18, the surgeon couples an end of each lead12 of the stimulator 10 to the exposed end of the monofilament 186 usingthe connector 188. As shown in FIG. 20, the end of the lead 12 isinserted through one end of the connector 188 and held via a frictionfit, and the end of the monofilament 186 is inserted through the otherend of the connector 188 and held via a friction fit. The surgeon maychoose to permanently couple the connector 188 with the lead 12 of thestimulator 10 and the monofilament 186 by applying a small amount ofadhesive to each end of the connector and the coupled lead/monofilament.Once the monofilament 186 is coupled with the lead 12 via the connector188, the surgeon then turns to the thoracic region 20. The surgeon pullsthe exposed monofilament 186 at the thoracic end 20 distally to pull themonofilament 186 through the epidural space. This in turn pulls the lead12 connected to monofilament 186 through the epidural space. The surgeonis the able to position the lead 12 within the desired location of thespinal column 22 by pulling the monofilament 186 from the thoracic end20.

As noted above, there may be multiple leads with multiple wires, andtherefore, multiple monofilaments. Once each monofilament is coupled toits respective lead, and each lead is positioned within the epiduralspace, the surgeon excises the skin at the lumbar region and removes theintroducer 172 located at the first access point. The surgeon thenapplies a sylastic anchor (not shown) to secure the lead wire 14 at thepatient's lumbar region. The surgeon prepares a pocket in the patient'slumbar region for the IPG 16, connects the first access point and thepocket for the IPG with a tunneling instrument (not shown), pulls thelead wire 14 through the tunneling instrument, and connects the leadwire to the IPG. As discussed above, the IPG 16 controls application ofvoltage to the leads 12, and the signal is sent through the lead wire14.

The surgeon then turns to the thoracic region 20 to secure the exposedmonofilament 186. Similar to the lead wire at the lumbar end 18, thesurgeon trims the monofilament 186 as needed. However, the surgeonleaves an exposed monofilament, referred to as a tension relief portion.The surgeon will use this exposed tension relief portion to move thelead 12 within the epidural space during the patient's ongoing use ofthe stimulator 10. Prior to securing the tension relief portion withinan excised portion of skin in the patient, the surgeon removes thecannula 32. To secure the tension relief portion, the surgeon forms aloop or otherwise gathers the exposed tension relief portion. Thesurgeon excises the skin at the thoracic end and prepares a pocket forsecuring the exposed tension relief portion. The surgeon secures thetension relief portion using sylastic anchors (not shown). Thus, thelead is secured, via the monofilament, at the thoracic end of thepatient.

In embodiments of the invention, the surgeon can move the lead(s) withinthe epidural space by gathering or releasing either or both of the leadwire(s) 14 connected to the leads 12 at the lumbar region 18 or themonofilament(s) 186 at the thoracic region 20. Because each percutaneouslead 12 is coupled to its respective monofilament 186 at the thoracicend 20, and the lead wire 14 is coupled to the lead 12 at the lumbar end18, the leads will not move axially within the epidural space once thelead wire and monofilament are secured with the anchors. However, thesurgeon can move the lead within the epidural space as desired.

Although the invention has been described with reference to theembodiments illustrated in the attached drawing figures, it is notedthat equivalents may be employed and substitutions made herein withoutdeparting from the scope of the invention as recited in the claims.Having thus described various embodiments of the invention, what isclaimed as new and desired to be protected by Letters Patent includesthe following:

1. A method of stabilizing electrical stimulators within the epiduralspace of a patient's spinal column, comprising: creating first andsecond access points for accessing the patient's epidural space;inserting a guide wire assembly into the epidural space through thesecond access point; receiving the guide wire assembly through the firstaccess point, wherein the guide wire assembly includes a hollowed guidewire sleeve presenting a guide wire sleeve lumen and a guide wire housedwithin the guide wire sleeve lumen; removing the guide wire from theguide wire sleeve lumen; feeding at least one monofilament through theguide wire sleeve lumen; removing the guide wire sleeve from theepidural space of the spinal column leaving the at least onemonofilament in place; coupling a percutaneous lead of a spinal cordstimulator to the at least one monofilament; pulling the percutaneouslead through at least a portion of the epidural space until thepercutaneous lead is at a desired position; and securing thepercutaneous lead at the desired position.
 2. The method of claim 1,wherein the first access point is at the patient's lumbar region and thesecond access point is at the patient's thoracic region.
 3. The methodof claim 1, wherein the patient's epidural space is accessed throughsoft tissue, inserting a combined needle and stylet into the soft tissueto access the epidural space;
 4. The method of claim 1, wherein theguide wire is received by a guide wire receiver comprising a scoop at areceiving end of the guide wire receiver.
 5. The method of claim 4,wherein the guide wire assembly further comprises a magnet on areceiving end of the guide wire assembly, and wherein the scoop isconfigured to receive the magnet.
 6. The method of claim 5, wherein theguide wire receiver further comprises a guide wire receiver lumen, andwherein an angiocath is fed through the guide wire receiver lumenpresenting a receiving magnet for attracting and receiving the magnet ofthe guide wire assembly.
 7. The method of claim 1, wherein thepercutaneous lead is coupled to the at least one monofilament with afriction fit connector.
 8. The method of claim 1, wherein thepercutaneous lead is secured by anchoring a portion of the at least onemonofilament exposed outside of the first or second access points andanchoring the percutaneous lead outside of the other of said first orsecond access points.
 9. The method of claim 8, wherein the step ofpositioning the percutaneous lead at the desired position within theepidural space is an initial positioning step, said method furthercomprising the step of: subsequent in time to the initial positioningstep, changing the position of the leads within the epidural space bygathering or releasing the exposed portion of the at least onemonofilament or said exposed portion of the percutaneous lead.
 10. Themethod of claim 1, wherein the patient's epidural space is accessed byinserting a cannula with a trocar onto the lamina of the patient,inserting a drill within a cannula lumen, and using the drill and anincremental drill adjuster to create the first access point.
 11. Amethod of stabilizing electrical stimulators within the epidural spaceof a patient's spinal column, comprising: creating first and secondaccess points to the patient's epidural space; inserting a guide wireassembly into the epidural space through the second access point;receiving the guide wire assembly through the first access point,wherein the guide wire assembly includes a hollowed guide wire sleevepresenting a guide wire sleeve lumen and a guide wire inserted throughthe guide wire sleeve lumen; removing the guide wire from the guide wiresleeve lumen; feeding at least one monofilament through the guide wiresleeve lumen; removing the guide wire sleeve from the epidural space ofthe spinal column leaving in place the at least one monofilament in theepidural space, such that a first length of the at least onemonofilament is exposed and external to the first access point, and asecond length of the at least one monofilament is exposed and externalto the second access point; coupling a percutaneous lead of a spinalcord stimulator to the first exposed length of the at least onemonofilament; pulling a percutaneous lead through at least a portion ofthe epidural space of the spinal column by pulling on the second exposedlength of the at least one monofilament to which the percutaneous leadis not coupled; and securing the percutaneous lead at a desiredposition.
 12. The method of claim 11, wherein the guide wire assemblyfurther comprises a magnet at a receiving end, and wherein, once theguide wire assembly is pulled through the epidural space and the magnetis exposed from either the first or second access points, the magnet isremoved from the guide wire assembly exposing the guide wire housedwithin the guide wire sleeve.
 13. The method of claim 11, wherein theguide wire receiver further comprises a guide wire receiver shaft, andwherein the guide wire receiver shaft is semi-cylindrical along aportion of its length to present an open lumen, and a scoop forreceiving the guide wire assembly is provided at the receiving end ofthe guide wire receiver shaft.
 14. The method of claim 11, wherein themonofilament is coupled to the percutaneous lead with a friction fitconnector.
 15. The method of claim 11, wherein the percutaneous lead andthe monofilament are permanently connected with a biocompatibleadhesive.
 16. A method of stabilizing electrical stimulators within theepidural space of a patient's spinal column, comprising: creating firstand second access points to the patient's epidural space; inserting aguide wire assembly into the epidural space through the second accesspoint; receiving the guide wire assembly through the first access pointwith a guide wire receiver, wherein a scoop is presented at a receivingend of the guide wire receiver for receiving the guide wire assembly,wherein the guide wire assembly includes a hollowed guide wire sleevepresenting a guide wire sleeve lumen and a guide wire housed within theguide wire sleeve lumen; pulling the guide wire assembly, using theguide wire receiver, through the epidural space to expose a portion ofthe guide wire assembly external to the first access point; removing theguide wire from the guide wire sleeve lumen; pulling at least onemonofilament through the guide wire sleeve lumen; removing the guidewire sleeve from the epidural space of the spinal column leaving the atleast one monofilament; coupling a percutaneous lead of a spinal cordstimulator to the at least one monofilament; pulling the percutaneouslead through at least a portion of the epidural space of the spinalcolumn until the percutaneous lead is at a desired position; andsecuring the percutaneous lead at the desired position by anchoring anexposed portion of the monofilament and an exposed portion of thepercutaneous lead.
 17. The method of claim 16, wherein the guide wireassembly further comprises a magnet on a receiving end of the guide wireassembly, and wherein the scoop is widened for receipt of the magnet.18. The method of claim 17, wherein the guide wire receiver furthercomprises a guide wire receiver shaft, and wherein the guide wirereceiver shaft is semi-cylindrical along a portion of its length topresent an open lumen, and the scoop is provided at a receiving end ofthe guide wire receiver shaft.
 19. The method of claim 16, wherein theguide wire sleeve is open on a first end and a second end such that theguide wire may be removed from either the first or second end.
 20. Themethod of claim 16, wherein the percutaneous lead and the monofilamentare permanently connected with a biocompatible adhesive.